Annexon to Present More Phase 2 Data on ANX007's Efficacy in Geographic Atrophy at 42nd ASRS Meeting

Annexon, Inc., a biopharmaceutical company specializing in treatments for neuroinflammatory diseases, has announced its participation in the upcoming American Society of Retina Specialists (ASRS) Annual Scientific Meeting. The event will take place from July 17-20, 2024, in Stockholm, Sweden, and will feature two presentations by Annexon on their lead drug candidate, ANX007.

The first presentation, a late-breaking oral presentation titled “Protective Effects of ANX007 on Central Macular Ellipsoid Zone (EZ) and Retinal Pigment Epithelium (RPE) and Association with Visual Acuity in the Phase 2 ARCHER GA Study,” will be delivered by Dr. Glenn J. Jaffe from the Duke Department of Ophthalmology. This presentation is scheduled for July 18, 2024, at 8:42 AM ET during the Imaging Symposium I session.

The second presentation, titled “Preservation of Vision by ANX007: Clinical Results and Anatomic Changes From the Phase 2 ARCHER Trial,” will be given by Dr. Joel Pearlman from the Retinal Consultants Medical Group. This talk is set for July 18, 2024, at 1:36 PM ET during the Dry AMD Symposium 2 session.

ANX007 is an innovative therapeutic antibody fragment designed to selectively inhibit C1q, the initiating molecule in the classical complement pathway, which is known to drive neurodegeneration. This pathway is particularly implicated in geographic atrophy (GA), a severe form of dry age-related macular degeneration (AMD) that leads to significant vision loss. In GA, C1q binds to photoreceptor synapses early in the disease, triggering an aberrant activation of the complement pathway, resulting in inflammation and neuronal damage.

The Phase 2 ARCHER clinical trial for ANX007 implemented a randomized, multi-center, double-masked, sham-controlled methodology to evaluate its efficacy. The trial demonstrated that ANX007 provides statistically significant protection against vision loss through several measures. These include the widely accepted ≥ 15 letter loss on best corrected visual acuity (BCVA≥15), low luminance visual acuity (LLVA), and low luminance visual deficit (LLVD). Protection increased over the treatment period, suggesting durable and growing benefits over time.

Retinal imaging techniques, such as optical coherence tomography (OCT) and fundus autofluorescence (FAF), showed that ANX007 also effectively protects retinal structures critical for vision. This includes significant preservation of photoreceptor cells and retinal pigment epithelial cells in the fovea. The treatment demonstrated a favorable safety profile over 12 months, with no increase in choroidal neovascularization (CNV) rates or instances of retinal vasculitis.

Geographic atrophy, the focus of ANX007's development, affects approximately one million people in the U.S. and eight million globally. GA is a progressive neurodegenerative disorder of the retina, associated with the loss of photoreceptor cells, severely impacting the quality of life for many elderly individuals. Despite its prevalence, there are no approved treatments that significantly prevent vision loss in GA, making ANX007 a promising candidate in this space.

Annexon Biosciences is committed to advancing treatments for neuroinflammatory diseases. Their approach targets the classical complement pathway to provide therapeutic benefits across a range of debilitating conditions, including Guillain-Barré syndrome, Huntington’s disease, and geographic atrophy. With promising Phase 2 results, Annexon is progressing towards later-stage clinical trials to bring these potential therapies to patients in need.